Study Evaluating the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT04026165
• Date of registration: 17/07/2019
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Study Evaluating the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease MOSAIC
• Scientific title: MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease
• Date of first enrolment: July 24, 2019
• Target sample size: 310
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04026165
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, Japan, New Zealand, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.

- eGFR value calculated by central laboratory utilizing samples collected during
screening and prior to enrollment of = 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with
albuminuria

- eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c

- a: eGFR (mL/min/1.73 m^2): = 45 to < 60; UACR (mg/g): = 600 to 5000

- b: eGFR (mL/min/1.73 m^2): = 30 to < 45; UACR (mg/g): = 300 to 5000

- c: eGFR (mL/min/1.73 m^2): = 20 to < 30; UACR (mg/g): = 150 to 5000

- Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin
receptor blocker (ARB)

- Individuals not receiving an ACEi or ARB may be enrolled if there is documented
intolerance to ACEi and ARB

- Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if
there is a documented reason that the maximum labeled dose of ACEi and ARB could
not be reached

- Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must
be on a stable dose for at least 2 weeks prior to enrollment

- Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure
(DBP) must be <100 mmHg

- Required baseline laboratory data, analyzed by central laboratory, within 30 days
prior to enrollment

Key Exclusion Criteria:

- HbA1c > 12.0% within 30 days prior to enrollment

- Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset
diabetes of the young (MODY)

- Body mass index (BMI) > 50 kg/m^2

- UACR > 5000 mg/g on any measurement during screening

- End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal
dialysis, or history of kidney transplantation)

- Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal
dialysis or receipt of kidney transplant) within 3 months after enrollment

- Unstable CV disease

- Pregnant or lactating females or planning to become pregnant or breastfeed during the
study

- Concurrent use of either

1. ACEi and ARB or

2. Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in
combination with an ACEi or ARB for at least 2 weeks prior to Enrollment

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could adversely affect the safety of the individual or impair the assessment
of study results

Note: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Kidney Disease

Intervention(s)

Drug: SEL

Drug: Placebo

Primary Outcome(s)

Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) Slope [Time Frame: Up to 100 weeks]

Secondary Outcome(s)

Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys) Slope [Time Frame: Up to 100 weeks]

Time From Randomization to First Occurrence of a Kidney Clinical Event [Time Frame: Up to 100 weeks]

Proportion of Kidney Clinical Events at Week 48 [Time Frame: Week 48]

Secondary ID(s)

JapicCTI-194911

GS-US-223-1017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors